Principal Pharmacometrician, FSP
Principal Pharmacometrician, FSP
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Job Description
Location: Home-based in the Canada
Why DSSS
Data Sciences Staffing Solutions DSSS or DS3 is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This affords all the benefits of working for an industry leading global CRO while operating within a sponsor team and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you a unique opportunity to work on a team where your role is both challenging and rewarding alongside colleagues who are passionate about influencing the future of medicine and advancing therapies. With IQVIAs DSSS you become a core part of a dynamic team dedicated to reshaping the future of healthcare.
Additional Benefits:
- Home-based remote work opportunities.
- Work/life balance.
- Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors.
- Cohesive team environment fostering a collaborative approach to study work.
- Variety of therapeutic areas indications and study phases.
- Job stability; long-term engagements and development opportunities.
- Career advancement opportunities.
Responsibilities:
- Contribute to development of protocols analysis plans PK/PD analysis and pharmacometric reports for pre-clinical or Phase I-IV clinical studies.
- Consult with Clinical Pharmacology staff on study design analyses clinical development plans.
- Plan and execute a wide range of pharmacometric analyses to inform clinical pharmacology and drug development decisions
- Prepare or review PK/PD sections of dossiers for product registration and communicate with regulatory agencies.
- Assess pharmacometric requirements for and ensure integration of pharmacometric information into drug development milestones and development decisions.
- Ensure quality and timely delivery of project PK/PD deliverables.
- Collaborate in cross functional teams that include Project Manager CRA Data Manager Biostatistician Programmer and/or Medical Writer.
- Maintain awareness of overall developments in the field of pharmacometrics and clinical pharmacology based on current literature application of new technology attendance at professional meetings etc.
Qualifications:
- PharmD Ph.D. (or equivalent) in pharmacology pharmacy pharmacometrics pharmaceutics biology mathematics statistics engineering or a field with significant modeling-related content/training required
- Minimum of 3 years experience in Pharmacokinetics or Pharmacology for Clinical Research Organization or pharmaceutical environment
- Minimum of 2 years in applying model-based methods in pre-clinical and clinical drug development
- Expert knowledge of pharmacometric concepts including compartmental and noncompartmental analysis population PK modeling current therapeutic environment and drug development trends.
- Scientific skills demonstrated in facilitating the (early/full) clinical development strategy
- Strong understanding of the principles of the drug development process ICH GCP and applicable international and national regulatory requirements
- Good problem solving and analytical skills
- Excellent computer skills including proficiency with Microsoft Office WinNonlin and graphing as well as NONMEM R and basic SAS programming
- Excellent verbal and written communication skills and highly effective interpersonal and organizational skills
- Ability to prioritize and independently coordinate and manage PK/PD component of complex projects
- Ability to interact in a cross-functional and multi-cultural team environment
- Ability to establish and maintain effective working relationships with coworkers managers and clients
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IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $105800.00 - $294800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.
Required Experience:
Staff IC
Employment Type
Full-Time
